- Associated Press - Friday, May 11, 2012

CHICAGO — A pill to prevent HIV infection is already being given to some healthy people, but without government approval, it remains out of reach and too costly for many who need it.

Doctors, patients and advocates say that would change if the Food and Drug Administration takes a landmark step and allows the pill, Truvada, to be marketed for prevention. The drug has been used for some time as a treatment for those already infected with the AIDS virus.

“This is a pretty radical step, but I think it’s a necessary step,” said Dr. Lisa Sterman of San Francisco, who prescribes the drug for already infected patients and those who are healthy but at risk of getting the virus from their partners or through risky sex.

“We’ve come as far as we can with condom use and safe sex strategies,” Sterman said.


A panel of advisers to the Food and Drug Administration late Thursday endorsed using Truvada as a preventive.

In the 30-year battle against AIDS, “it’s the first time we have talked about a medication for prevention of HIV,” Sterman said.

Doctors are allowed to prescribe Truvada “off-label” for prevention, but FDA approval would formally allow the pill’s maker Gilead Sciences to market it for that use. It would probably lead many more insurance companies to pay for the costly drug. The FDA usually follows advisers’ recommendations and a decision is expected by June 15.

The panel’s action “is a huge step forward,” said Nick Literski, a federal worker in Seattle who has been taking Truvada for HIV prevention for more than a year. His partner has the AIDS virus. Literski’s insurance covers his preventive treatment. The pill’s annual cost ranges from just under $11,000 up to $14,000.

Using the drug for prevention “is really allowing people to make educated choices about their health,” Literski said.

An estimated 1.2 million Americans have HIV and many more worldwide. AIDS can develop unless the virus is treated with antiviral drugs. The success of such medicines has helped make the disease more manageable and allows patients to live much longer than when the epidemic began 30 years ago.

About 50,000 new HIV infections are diagnosed in the U.S. each year — a number that has held steady for about 15 years.

“We’re going to have to take some radical steps in order to stop this epidemic,” Sterman said.

Truvada is marketed by Gilead Sciences Inc. of Foster City, Calif. Studies have shown daily use is highly effective at preventing HIV infections.

Some Truvada prevention studies took place in Africa, and the drug is available as an HIV treatment there and in poor nations elsewhere, but Gilead is seeking approval for using it for prevention in the United States only, a company spokeswoman said.

A September editorial in the medical journal Lancet raised concerns about using HIV treatments for prevention when many HIV infected people globally lack access to effective treatments.

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